The present invention relates to a novel voice prosthesis device which is insertable through a fistula to connect and channel air directly from the lungs through the trachea to the esophagus for voice restoration after a total laryngectomy.
In the past, voice prosthesis devices have been suggested for insertion into a fistula to connect the tracheostoma with the esophagus to channel air from the lungs to the esophagus to permit alaryngeal speech by the patient or user. One such voice prosthesis device is disclosed in our co-pending application Ser. No. 316,055, filed on Oct. 29, 1981, and entitled "Method and Apparatus for a Tracheal Valve", and in a paper entitled "An Endoscopic Technique For Restoration of Voice After Laryngectomy", Annals of Otology, Rhinology and Laryngology, 1980, Vol. 89, No. 6. However, the elongated hollow tube or duck-bill type valve slit in the elongated hollow tube requires approximately 90 centimeters of water pressure before the duck-bill type valve opens to permit air to enter the esophagus for speaking. Additionally, a voice prosthesis device, known as the Panje device, is a shorted criss-crossed slitted duck-bill device, which includes self-retaining flanges which abut against each side of the tracheoesophageal wall to hold the device in the fistula. However, the Panje type device requires approximately 400 centimeters of water pressure before voice sounds are achieved, a pressure which is totally unsatisfactory for most, if not all, patients or users. Because a normal larynx requires approximately 35 centimeters of water pressure for speech, it can be seen that a voice prosthesis device, which closely approximates normal voice pressure, is highly desirable and has been unattained by the duck-bill type prior art devices.
Additionally, U.S. Pat. No. 3,747,127 discloses a fistula valve FA which is merely a check valve mounted on the outside of the exterior proximal end of a tubular extension. Because the valve opens and closes from the top of the proximal end and is unprotected because it is not in a recessed position within the tube, such a structure is unsatisfactory in communicating between the trachea and the esophagus because the valve is readily exposed to the esophageal contents, and liquids and matter therein may penetrate the valve from the esophagus with resultant aspiration into the lungs of the user or patient. Accordingly, such devices have found no limited application in restoring speech to patients having a total laryngectomy.